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Monoclonal Antibodies

Chemotherapy + Immunotherapy for Esophageal Cancer

Phase 2

Recruiting

Led By Mariela Blum

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (1500/uL) without granulocyte colony-stimulating factor support (obtained within 14 days prior to initiation of study treatment)

Patients with T1N1, and T2-3 with any N will be eligible

Must not have

Patients with T1aN0, T4b, or M1 cancer will be excluded

Patients with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of atezolizumab, oxaliplatin, and fluorouracil to treat patients with esophageal or gastroesophageal cancer.

Who is the study for?

This trial is for adults with localized esophageal or gastroesophageal adenocarcinoma who haven't had prior treatments. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception, and be medically fit for surgery. People with specific other health conditions or cancers are excluded.

What is being tested?

The study tests if atezolizumab combined with chemotherapy (oxaliplatin and fluorouracil) before surgery can control cancer better than current methods. It also examines the addition of tiragolumab to this combination to see if it offers further benefits.

What are the potential side effects?

Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drugs being administered, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My white blood cell count is healthy without needing medication.

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My cancer is in an early stage but has spread to nearby lymph nodes.

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My platelet count is at least 100,000 without needing a transfusion.

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I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.

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My cancer is a type of esophageal or gastroesophageal adenocarcinoma.

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I have not had any chemotherapy or radiation therapy before.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is not classified as T1aN0, T4b, or M1.

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I tested negative for HBsAg and positive for HBcAb.

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I do not have uncontrolled diabetes, heart issues, high blood pressure, or mental health conditions that would prevent my participation.

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I have active tuberculosis.

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My primary tumor is actively bleeding and needs radiation.

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My calcium levels are not higher than normal and I don't have symptoms of high calcium.

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I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.

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I have an active hepatitis B infection.

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I am allergic to oxaliplatin or 5-FU medications.

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I have a history of certain lung conditions or signs of lung inflammation on a recent CT scan.

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I have an active hepatitis C infection confirmed by tests.

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I have previously been treated with specific immune therapies.

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My cancer has spread to nearby organs and there's a risk of developing a fistula.

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I have had a stem cell or organ transplant in the past.

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My cancer is identified as squamous cell carcinoma.

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I have not had a severe infection or been hospitalized for one in the last 4 weeks.

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I experience significant numbness or pain in my hands or feet.

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I do not have serious heart problems like recent heart attacks or unstable heart conditions.

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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pathological complete response (PathCR)

Secondary study objectives

Changes in tumor stroma profile after treatment

Disease-free survival (DFS)

Overall survival (OS)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Dysgeusia

Headache

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2- Atezolizumab plus and Tiragolumab with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment5 Interventions

The combination of Atezolizumab + Tiragolumab with Oxaliplatin and 5-Flourouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab + Tiragolumab on Day 1 of each 21-day cycle for a total of 48 weeks.

Group II: Cohort 1-Atezolizumab combination with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment4 Interventions

The combination of Atezolizumab with Oxaliplatin and 5-Fluorouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab on Day 1 of each 21-day cycle for total of 24 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

2011

Completed Phase 4

~2890

Tiragolumab

2019

Completed Phase 3

~2330